Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety of ab-1003 (previously lion-101) in subjects with genetic confirmation of lgmd2i/r9 (part1)

Conditions: Limb Girdle Muscular Dystrophy; Limb-Girdle Muscular Dystrophy Type 2; LGMD2I; Muscular Dystrophy; LGMD2; LGMD; FKRP; FKRP Mutation; Fukutin Related Protein

Summary: the purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of ab-1003 in adults diagnosed with limb girdle muscular dystrophy type 2i/r9 (lgmd2i/r9). participants will be treated in sequential, dose-level cohorts. (part 1)


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 18 and 65 years with clinical diagnosis of lgmd2i/r9 and confirmation of fkrp gene mutation. 2. ability to ascend 4 stairs between 2.5 and 10 seconds. 3. ability to walk/run 10 meters in \<30 seconds. 4. able to understand and comply with all study procedures. 5. sexually active females of childbearing potential and female and male partners of male subjects receiving study intervention must use a barrier method of contraception for the first 6 months after dosing. exclusion criteria: 1. significant cardiomyopathy as defined by echocardiogram (left ventricular ejection fraction \ 480m/sec), nyha class 3 or 4 heart failure, or mri gadolinium enhancement evidence of clinically important myocardial fibrosis. 2. contraindication to mri or hypersensitivity to contrast dyes, shellfish or iodine. 3. implanted spinal rods, cardiac pacemaker or other implantation that would distort cardiac mri images. 4. history of active, ongoing chronic liver disease (e.g. hepatitis, hiv-related liver disease, hemochromatosis, steatosis, etc.) or abnormal liver function tests (abnormal ggt and/or abnormal total/direct bilirubin \>upper limit of normal \[uln\] and/or elevated ast and alt \>2 uln). 5. abnormal renal function (gfr \<60 ml/min, using the modification of diet in renal disease equation). 6. any life-threatening disease, including malignant neoplasms and medical history or malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer). 7. in the opinion of the investigator, a pre-existing medical condition that predisposes the subject to risks that outweighs the potential benefits. 8. requirement for daytime ventilatory support. 9. change in glucocorticosteroid treatment within 3 months prior to screening visit. 10. exposure to another investigational drug within 3 months prior to study treatment or any previous treatment with gene therapy. 11. ongoing participation in any other therapeutic clinical trial. 12. neutralizing antibody titer to aav9 ≥1:5. 13. female subjects who are pregnant, plan to become pregnant in the next 12 months, or breastfeeding.

Keywords: gene therapy lgmd2i lgmd2i/r9 gene augmentation therapy fkrp fukutin related protein fkrp mutation
an explorative prospective observational study to describe morphokinetic de-selection parameters in human embryos

Conditions: Infertility

Summary: this post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.


Eligibility criteria:
inclusion criteria: * age 21-45 years * in vitro fertilisation/intra cytoplasmic sperm injection treatment in long or short protocol * receiving follicle stimulation with menopur 600/1200 iu
a trial of td0019 in treatment of cervical scapulohumeral syndrome

Conditions: Syndrome Pain

Summary: cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. the physical syndromes vary from neck pain, sensory processing disorder/movenment disorder of areas dominated by injured nerves. the hard capsule td0019 is a product based on the traditional prescription named "độc hoạt tang ký sinh thang" combined with nattokinase and the extraction of salix alba cortex .

cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. the physical syndromes vary from neck pain, hands, accompanied by a sensory processing disorder/movenment disorder of areas dominated by injured nerves. the most common reason is cervical spondylosis the hard capsule td0019 is a product based on the traditional prescription named "độc hoạt tang ký sinh thang" combined with nattokinase and the extraction of salix alba cortex. the trial lasts for 24 months with 4 subject visits (from t0 to t3) and is conducted in national hospital of traditional medicine (hanoi, vietnam). screening procedure occurs at t0 visit, followed by t1 (15+-3 days) and t2 (30+-3 days). there are 2 levels of dosages: basic dose (arm 1) and 1.5x (arm 2) of basic dose. there is also another arm using placebo, thus the trial have 3 arms in total.

Eligibility criteria:
inclusion criteria: subject must meet all below criteria to be enrolled: * subjects diagnosed with cervical scapulohumeral syndrome according to the guideline of vietnam moh 2014 * age \> 18 at time of signing icf, male or female. * no contraindications with oral nsaids. * agree and and sign in the icf exclusion criteria: subjects will be excluded in the trial if any of the below are met: * hypersensitivity to any subtances of td0019 or any nsaids. * pregnant or lactating. * currently having surgical indications. * movement disorders, diabetes, myasthenia, alcoholism * other conditions asseted by the investigator that are not eligible to be enrolled. * cervical scapulohumeral syndrome caused by tumor, infection, hypertension, physical injured. * arrhythmia, hypertension. * hypertensitivity to meloxicam or its excipients. * cross - hypertensitivity to aspirin or other nsaids. * peptic ulcer * severe liver failure * severe renal failure without dialysis. * gastrointestinal hemorrhage, recent brain hemorrhage. * uncontrolled heart failure. * alcoholism, movement disorders, diabetes, muscular dystrophy.
cultivating well-being in severe psychiatric conditions

Conditions: Wellbeing

Summary: the multicomponet psychological intervention is called feliz-mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. feliz-mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. the design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility criteria:
inclusion criteria: * 1) were aged 18-65 years * 2) had a minimum of motivation and commitment to participate in group therapy exclusion criteria: * 1) limited cognitive resources or serious formal thinking disorder and/or * 2) a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.

Keywords: schizophrenia severe psychiatric conditions wellbeing rct positive psychology third-generation psychotherapy
telehealth mindfulness-based music and songwriting for parents of children with intellectual/developmental disabilities

Conditions: Parents; Stress; Developmental Disability; Intellectual Disability; Autism Spectrum Disorder

Summary: this is a pilot study of the feasibility and potential impact of a mindfulness-based music and songwriting program (delivered via telehealth) on stress and well-being in parents/caregivers of children with intellectual or developmental disabilities. participants are randomized to participate in the mindfulness program or a business-as-usual control group.

this is a pilot study of the feasibility and potential impact of a mindfulness-based music and songwriting program (delivered via telehealth) on stress and well-being in parents/caregivers of children with intellectual or developmental disabilities. participants are randomized to participate in the mindfulness program or a business-as-usual control group. during mindfulness sessions, parents/caregivers are supported by a therapist to learn and apply mindfulness practices through music-based meditations and songwriting. participants write two songs during the program. parents complete surveys throughout the program.

Eligibility criteria:
inclusion criteria: * parent/caregiver of a child with an intellectual or developmental disability * parent speaks and reads fluent english * able to attend weekly telehealth/virtual sessions exclusion criteria: -
evaluation of the effectiveness and safety of ai-robotics

Conditions: Lower Extremity Motor Dysfunction, Spinal Cord Injury

Summary: evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot developed by ai-robotics technology co., ltd., beijing for who had lower limb paralysis

Eligibility criteria:
inclusion criteria: 1. more than18 but less than 60 years old，less than 80 kilos of weight，gender is not limited 2. confirmed by mr/ct，ais spinal cord injury grade: a-c level (without walking ability)：damage plane t6-l2 3. the muscle tension of the modified ashworth grade level is less than or equal to 2 4. the range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint neutral position 5. upper limb strength and physical strength are sufficient to stabilize the crutches 6. patients are able to understand and actively participate in the training program, agree and sign the informed consent form exclusion criteria: 1. the range of motion of the joints is severely limited and the walking action is limited 2. spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing 3. skin injury or infection of the lower extremities or the part of wearing robot 4. unstable angina, severe arrhythmia and other heart diseases 5. severe chronic obstructive pulmonary disease 6. unilateral neglect 7. severe cognitive or visual impairment 8. other contraindications or complications that may affect walking training 9. pregnant or lactating women 10. the investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements

Keywords: paralysis lower extremities ai-robotics
lung function changes of induced asthma children treated with inhaled mgso4

Conditions: Asthma

Summary: as a non-selective bronchodilator, magnesium sulfate (mgso4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and pef. however, the use of intravenous mgso4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. the aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. at present, there are only a few studies about the effects of nebulized mgso4 in the treatment of acute asthma in children, and the conclusions are controversial.


Eligibility criteria:
inclusion criteria: * known cases of controlled bronchial asthma * ≧4 years of age * the result was positive after acetylcholine provocation test in follow-up visit exclusion criteria: * had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day * had fever (axillary temperature\>38.5℃) * history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis * history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium

Keywords: magnesium sulfate nebulized lung function
effects of online training aimed at increasing participation in everyday life during a pandemic (scd online).

Conditions: Subjective Cognitive Decline

Summary: this study evaluates the efficacy of real-world strategy training (rwst) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (scd). participants will be randomly assigned to receive one of these approaches. additionally, this study will provide insight into the benefits of the program while people are not able to meet in person during a pandemic.

evidence suggests that 25-50% of community-dwelling older adults report scd and that these individuals have an elevated risk for developing mild cognitive impairment and/or dementia. many of these individuals report difficulties with complex activities of daily living. rwst aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. the approach is provided within the context of individually identified everyday-life difficulties. the psycho-education approach is a brain-health workshop supplemented by intellectually stimulating activities such as doing sudoku and/or word searches. this approach provides information people may use to inform health behaviour changes.

Eligibility criteria:
inclusion criteria: * have access to high speed internet and a computer or mobile device with a webcam * have subjective cognitive complaints * be fluent in written and spoken english * able to self-identify areas of their everyday lives in which they would like to improve. exclusion criteria: * diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, parkinson's) * presence of severe depression * presence of substance abuse * history of hospitalization for psychiatric reasons

Keywords: age-related cognitive changes
belgian real life non-interventional study (nis) in patients treated with xarelto following an acute deep vein thrombosis (dvt)

Conditions: Venous Thrombosis

Summary: the objective of this nis is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with xarelto, in accordance with the terms of the european marketing authorization and the belgian reimbursement criteria.


Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of deep vein thrombosis (dvt) within the past 9 months, enabling at least 3 months of therapy exclusion criteria: * patients who do not fulfil the belgian reimbursement criteria of deep vein thrombosis (dvt)

Keywords: treatment of acute deep vein thrombosis prevention of recurrence oral anticoagulation real-life setting
twenty-four hour combined multi-channel impedance and ph ambulatory monitoring: impedance reflux episodes of patients on and off proton pump inhibitor therapy

Conditions: GERD

Summary: the purpose of this study is to determine the effects of proton pump inhibitors (ppis) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (gerd) based on 24-hour ph testing. in addition to changing the acidity of the refluxate, the investigators hypothesize that ppis also reduce the total number of reflux episodes due to its anti-secretory effects.


Eligibility criteria:
inclusion criteria: * all adults patients (age 18 or older) with reflux symptoms willing to participate exclusion criteria: * pregnancy * prior esophageal or gastric surgery * achalasia * scleroderma * gastroparesis.

Keywords: impedance reflux gerd
blood glucose monitoring systems: discounter versus brand

Conditions: Diabetes Mellitus

Summary: this study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to iso 15197 under the aspect of the system's prospected costs for the user.


Eligibility criteria:
inclusion criteria: * male or female, with clinical indication for blood glucose measurement * signed informed consent form * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study. exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion) * current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * a current constitution that does not allow participating in the study (e.g. hematocrit out of bgm specifications, medication known to influence blood glucose measurements; see appendix a of iso 15197) * being unable to give informed consent * \< 18 years * legally incompetent
the effect of methylphenidate on cognitive abilities of adults with bipolar disorder

Conditions: BD

Summary: the purpose of the study is to explore the effect of mph on working memory, attention and decision making in adults with bd in remission or in depressed state. the results will be compared to findings in healthy adults and adults with adhd. the investigators hypothesize that mph will incur improved performance in all measures.

following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at shalvata mhc twice. visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of mph or placebo.

Eligibility criteria:
inclusion criteria: * hebrew speakers * age 21-50 * diagnosis of bd i or ii (296.7 and 296.89 classifications in the dsm-iv-tr), according to medical records. diagnosis will be confirmed by a psychiatrist during screening process using the structured clinical interview for dsm-iv-tr (scid). exclusion criteria: * diagnosis of a clinical disorder other than bd or add/adhd which may impair performance on tasks used in the study. * bd patients diagnosed with an acute manic episode at screening, as established by ymrs\>8. it will also be required that 3 months have elapsed since the latest manic state, according to the patients' history. * participants for whom there exists a contra-indication for consuming ritalin. * pregnancy or current breastfeeding; female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study. * drug use in the previous 6 weeks according to participants' self report * electroconvulsive therapy (ect) in the previous 6 months

Keywords: bipolar disorder methylphenidate cognitive function
a research study to explore the impact of gp support via text messages to patients with asthma and/or copd

Conditions: Asthma; COPD

Summary: a 6-month randomised controlled trial to evaluate the impact of text message support on symptom control and inhaler adherence for patients with asthma and/or copd

this trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. the trial is multicentre and is non-blind. all patients in both groups will continue to receive their usual care for the duration of the study. randomisation will be at the individual level. participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the microsoft .net framework. this is a behavioural intervention. the intervention will consist of a series of supportive text messages to patients from their gp practice over a 6 month period. the messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. the content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler. all participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent and to comply with the study instructions 2. male and females age 18 or older 3. confirmed diagnosis of asthma and/or copd as recorded in the patient's gp medical record 4. currently prescribed a preventer inhaler 5. access to a mobile phone 6. ability to check text messages on phone 7. ability to read exclusion criteria: 1. inability to understand the study procedures 2. inability or reluctance to provide responses to the study questionnaires 3. inability to receive and respond to text messages